NorthWest Biotherapeutics Inc (NWBO)

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October 28, 2021

In the UK, an HTA license is required for the collection, processing and storage of human tissues and cells for medical purposes. This includes the tumor tissues used to prepare the lysate for DCVax-L products, and the immune cells that comprise the active ingredient of DCVax-L. Obtaining such a license requires an application, inspection and certification process. This process has now been completed and the HTA license allowing the relevant activities to be conducted at Sawston for DCVax-L has been issued.

The Sawston facility must also be certified and licensed by MHRA in order to be able to manufacture products such as DCVax-L. The process involves an extensive application process, comprehensive inspection of all aspects of the physical facility, its construction and equipment, and all aspects of the facility’s operations, including all operating systems, flow of materials and activities, sterility, quality control, staffing and other factors. It also includes extensive scrutiny of the quality management system that comprises approximately 1,000 regulatory documents, including standard operating procedures (SOPs) for the facility and for the product, validation records, data from practice manufacturing runs and other required documents.

Intensive preparations have been under way all year for this comprehensive inspection. A detailed application package and data were submitted to MHRA to qualify for the inspection. The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end. — NWBO